Specialized pharma analytical consultancy to Pharmaceutical industry and/or its subsidiary alliance across various functions viz,
- R&D
- Analytical Development
- Quality control
- Quality Assurance
- Regulatory submissions
- Data integrity
- Control strategy & Specifications
- GTI evaluation
- GAP assessment
- How to avoid/address analytical deficiencies
- Customized internal training.
Design specifications of raw materials, intermediates and final API inline with ICH Q11 requirements.
Verify the schemes and provide GAP analysis reports by understanding the Reaction schemes as per the current regulatory requirements for new submissions/ already submitted products.